FDA MedWatch 3500A (October 2015 Version) Generation Mapping

Learn how Vault generates the October 2015 version of the FDA MedWatch 3500A form from a Case. For details about the available FDA MedWatch 3500A formats supported by Safety and how Vault handles certain data during form generation, see FDA Report Formats.

FDA MedWatch 3500A (October 2015 Version) Header Section

FDA MedWatch 3500A Field Populated Value
Mfr. Report # The value from the UID field on the Case.

A. Patient Information

A. Patient Information Section

FDA MedWatch 3500A Field Populated Value
1. Patient Identifier The Patient Initials / ID on the Case. If blank, Vault populates the Investigation MRN value.
2. Age The value from one of the following Case fields, ordered by priority:
  1. Age (value and unit)
  2. Age (normalized)
2. Date of Birth The Date of Birth on the Case.
3. Sex The Sex on the Case.
4. Weight The value from one of the following Case fields, ordered by priority:
  1. Weight (value and unit)
  2. Weight (normalized)
5.a. Ethnicity The Ethnicity on the Case.
5.b. Race The Race on the Case.

B. Adverse Event or Product Problem

B. Adverse Event or Product Problem Section

FDA MedWatch 3500A Field Populated Value
1. Type of Report Based on the report type, Vault selects:
  • For non-device Cases, the Adverse Event checkbox.
  • For device or Combination Product Cases, one or both checkboxes. Vault selects the Product Problem checkbox if the Device Report Type includes Malfunction or Product Problem.
2. Outcome Attributed to Adverse Event Vault selects the appropriate checkbox based on the Seriousness of the Case. If the adverse event resulted in death, Vault populates the Date of Death on the Case.
3. Date of Event The earliest Onset Date for any Case Adverse Event associated with the Case.
4. Date of this Report The date when the report was generated, according to the Vault's timezone.
5. Describe Event or Problem Any text in the Narrative on the Case. After the narrative text, Vault populates any text in the Company Comments field. If the narrative text overflows onto additional pages, Company Comments also appear on the overflow pages.
6. Relevant Tests/Laboratory Data, Including Dates

On each row, Vault populates a Case Test Result. Records appear alphabetically and from oldest to latest.

The information exported includes:

  • [Test Name (MedDRA) and Test Name (Reported)],
  • Test Date,
  • [Result (Code) or Test Result Qualifier + Result Value + Result (Unit) or Result (Unit) Text],
  • Result (Text),
  • (Normal Low Value - Normal High Value) Result (Unit) or Result (Unit) Text,
  • Result (Text),
  • Comments

In addition, if the adverse event resulted in death, Vault populates the following Case Cause of Death information:

  • Reported Causes of Death: [Cause (MedDRA) or Cause (Reported)]
  • Autopsy-Determined Cause of Death: [Cause (MedDRA) or Cause (Reported)]
7. Other Relevant History, Including Preexisting Medical Conditions

For each Case Medical History record, Vault populates:

  • Disease / Surgical Procedure (MedDRA),
  • [Start Date or ---] to [End Date or --- or Continuing],
  • Comments

After listing each medical history line item, Vault populates any Medical History Text on the Case.

C. Suspect Products

C. Suspect Product(s) Section

FDA MedWatch 3500A Field Populated Value
1. Name and Strength, Manufacturer/Compounder

For Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered, Vault populates:

  • Name and Strength: Depending on your Admin's configuration, Vault first attempts to map the Product (Reported) or the Product (Coded) value from the Case Product. If the configured default value is blank, Vault maps the other value, if available.
  • NDC # or Unique ID: The National Drug Code on the associated Product Registration.
  • Manufacturer/Compounder: The Manufacturer on the associated Product. If blank, Vault maps the Organization on the associated Product Family.
  • Lot #: The Batch/Lot Number on the Case Product Dosage.
2. Concomitant Medical Products and Therapy Dates

For each Case Product, Vault populates:

  • [Product or Product (Reported)],
  • [First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration) Action(s) Taken,
  • [Dose or Dose Text] + Frequency,
  • Indication

If the therapy dates are unknown, Vault populates the Duration on the Case Product Dosage. Vault populates Ongoing if the Action Taken on the Case Product is any of the following:

  • Dose reduced
  • Dose increased
  • Dose not changed
3. Dose, Frequency, Route Used

For Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered, Vault populates:

  • Dose: The Dose value and unit or the Dose Text on the Case Product.
  • Frequency: The Frequency value and unit on the Case Product.
  • Route Used: The Patient RoA or Patient RoA (Reported) on the Case Product Dosage.
4. Therapy Dates

Vault populates Case Product information using the following priority:

  1. From the Case Product Dosage, the First Admin Date or --- or unk, Last Admin Date or --- or unk.
  2. If the therapy dates are blank and the Action Taken on the Case Product is any of the following, Vault populates Ongoing in the Duration field:
    • Dose reduced
    • Dose increased
    • Dose not changed
  3. If the Action Taken is blank, from the Case Product Dosage, the Duration.
5. Diagnosis for Use The Name (MedDRA) or Indication (Reported) on the Case Product Indication.
6. Is the Product Compounded? If any value is selected in the Compounding Type field on the Case Product Registration, then the Compounded checkbox is selected.
7. Is the Product Over-the-Counter? For each Case Product section, if any part of the Product has an FDA registration with the Registered As field set to a Transmission Product Type of OTC Drug, the Yes checkbox is selected. Otherwise, the field is left blank.
8. Expiration Date The Expiration Date on the Case Product.
9. Event Abated After Use Stopped or Dose Reduced? Vault calculates whether a dechallenge test occurred using the following fields:
  • Action Taken on the primary Case Product
  • Outcome on the primary Case Adverse Event

Based on the field values, Vault populates the form as follows:

Action Taken (G.k.8) E2B Code* Outcome (E.i.7) FDA 3500A C.9 Box
Drug Withdrawn
Dose Reduced		 1
2		 Recovered/Resolved
Recovering/Resolving
Recovered/Resolved with Sequalea		 Yes
Drug Withdrawn
Dose Reduced		 1
2		 Not Recovered
Not Resolved
Ongoing
Fatal		 No
Drug Withdrawn
Dose Reduced		 1
2		 Unknown (blank) (blank)
Dose Increased
Dose Not Changed
Not Applicable		 3
4
9		 Any Doesn't apply
Unknown 0 Any (blank)
Any other condition (blank)
*Includes custom Action Taken Controlled Vocabulary records
10. Event Reappeared After Reintroduction? Vault uses the Reaction Recurrence field on the primary Case Assessment to determine whether a rechallenge test occurred and populate the appropriate checkbox.
  • If the Reaction Recurrence value is yes – yes (rechallenge was done, reaction recurred), Vault selects the Yes checkbox.
  • If the Reaction Recurrence value is yes - no (rechallenge was done, reaction did not recur), Vault selects the No checkbox.
  • If the Reaction Recurrence value is any of the following, Vault selects the Doesn't apply checkbox:
    • yes - unk (rechallenge was done, outcome unknown)
    • no - n/a (no rechallenge was done, recurrence is not applicable)
    • Blank

D. Suspect Medical Device

D. Suspect Medical Device Section

FDA MedWatch 3500A Field Populated Value
1. Brand Name

The Product (Reported) on the Device-type Case Product.
2. Common Device Name The Generic Name on the associated Product.
2b. Procode The Product Code on the associated Product Registration.
3. Manufacturer Name, City and State If the Manufacturer field on the associated Product Family is an Organization, Vault populates the associated name, city, and state. Otherwise, Vault populates the Organization of the associated Product Family.
4. Model # The Model Number on the Device-type Case Product.
4. Lot # The Lot Number on the Device-type Case Product.
4. Catalog # The Catalog Number on the Device-type Case Product.
4. Expiration Date The Expiration Date on the Device-type Case Product.
4. Serial # The Serial Number on the Device-type Case Product.
4. Unique Identifier (UDI) # The Unique Identifier on the Device-type Case Product.
5. Operator of Device The Operator of Device on the Device-type Case Product.
6. If Implanted, Give Date The Date Implanted on the Device-type Case Product.
7. If Explanted, Give Date The Date Explanted on the Device-type Case Product.
8. Is this a single-use device that was reprocessed and reused on a patient? Vault selects the appropriate checkbox based on the Reprocessed/Reused field on the Device-type Case Product.
9. If Yes to Item 8, Enter Name and Address of Reprocessor The Reprocessor value on the Device-type Case Product.
10. Device Available for Evaluation? Vault selects the appropriate checkbox based on the Device Available field on the Device-type Case Product. If there is a Returned Date, Vault populates the date and selects the Returned to Manufacturer checkbox.
11. Concomitant Medical Products and Therapy Dates

For each Case Product, Vault populates values from the following fields:

  • [Product or Product (Reported)],
  • [First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration) Action(s) Taken,
  • [Dose or Dose Text] + Frequency,
  • Indication

If the therapy dates are unknown, Vault populates the Duration on the Case Product Dosage. Vault populates Ongoing if the Action Taken on the Case Product is any of the following:

  • Dose reduced
  • Dose increased
  • Dose not changed

E. Initial Reporter

E. Initial Reporter Section

FDA MedWatch 3500A Field Populated Value
1. Name and Address The name and address on the primary Reporter-type Case Contact.
2. Health Professional? Vault selects the appropriate checkbox based on the Qualification on the primary Reporter-type Case Contact.
3. Occupation The Qualification on the primary Reporter-type Case Contact.
4. Initial Reporter Also Sent Report to FDA Vault selects the appropriate checkbox based on the Sent to FDA? field on the primary Reporter-type Case Contact.

F. For Use by User Facility/Importer (Devices Only)

F. For Use by User Facility/Importer (Devices Only)

G. All Manufacturers

G. All Manufacturers Section

FDA MedWatch 3500A Field Populated Value
1. Contact Office (and Manufacturing Site for Devices) or Compounding Outsourcing Facility The contact information for the Sender User on the associated Transmission (Submission or Distribution). When generating a form preview from a Case, Vault populates contact details for the Organization on the Case.
2. Phone Number

When generating a form for submission or distribution, Vault populates the phone number for the user selected in the Sender User field on the associated Transmission (Submission or Distribution) record.

When generating a form preview from the Case, Vault populates the phone number for the organization selected in the Manufacturer on the Product record associated with the Case Product.
3. Report Source Vault selects the appropriate checkboxes as follows:
  • Foreign: Selected based on the Country on the primary Reporter-type Case Contact
  • Study: Selected when the Report Type of the Case corresponds to a Report Type controlled vocabulary where the E2B Code is 2, for example, Study or Literature (Study).
  • Literature: Selected when the Report Type of the Case corresponds to a Report Type controlled vocabulary where Literature is set to Yes, for example, Literature (Spontaneous) or Literature (Study).
  • Consumer: Selected when the Qualification of the Reporter-type Case Contact corresponds to a Qualification controlled vocabulary where Qualified HCP is set to No, for example, Consumer or other non health professional.
  • Health Professional: Selected when the Qualification of the Reporter-type Case Contact corresponds to a Qualification controlled vocabulary where Qualified HCP is set to Yes, for example, Physician.
  • User Facility: Selected when the FDA 3500A Report Source is User Facility on the primary Reporter-type Case Contact.
  • Company Representative: Selected when the FDA 3500A Report Source is Company Representative on the primary Reporter-type Case Contact.
  • Distributor: Selected when the FDA 3500A Report Source is Distributor on the primary Reporter-type Case Contact.
  • Other: Selected when the FDA 3500A Report Source is Other on the primary Reporter-type Case Contact. Vault also populates the Case Identifier from the associated Transmission (Submission or Distribution).
4. Date Received by Manufacturer

Vault uses the following logic to populate this field:

Initial Case: Vault maps the date from one of the following Case fields, ordered by priority:

  1. New Info Date
  2. Initial Receipt Date

A Case is considered initial when it meets any of the following conditions:

  • For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code I (Initial)
  • For a report preview generated from a Case, the Case Version must be less than or equal to 1.0

Follow-Up: Vault maps the date from the New Info Date field on the Case, if populated. A Case is considered follow-up when it meets any of the following conditions:

  • For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code I.
  • For a report preview generated from a Case, the Case Version must be greater than 1.0
5. NDA # If the Registration Type on the associated Product Registration is NDA, Vault maps the Registration Number.
5. ANDA # If the Registration Type on the associated Product Registration is ANDA, Vault maps the Registration Number.
5. IND #

For study Cases with a Study Type of Clinical Trial or blank, if there is a US Study Registration with a Registration Type of IND, Vault populates the IND number from the Study Registration Number field from that Study Registration.

In all other scenarios, if the Registration Type on the Case Product Registration is IND, Vault populates the Registration Number.
5. BLA # If the Registration Type on the associated Product Registration is BLA, Vault maps the Registration Number.
5. PMA/510(k) # If the Registration Type on the associated Product Registration is either PMA or 510k, Vault maps the Registration Number.
5. Combination Product Vault selects this checkbox when any Case Product is part of a Combination Product.
5. Pre-1938 If the International Birthdate on the associated Product is earlier than 1938, Vault selects this checkbox.
5. OTC Across all Case Products in sections C and D, if any part of a Product has an FDA registration with the Registered As field set to a Transmission Product Type of OTC Drug or OTC Device, Vault selects the Yes checkbox.
6. If IND/PreANDA, Give Protocol # The Sponsor Study Number on the Case.
7. Type of Report Vault selects the appropriate checkbox based on the value in the FDA Report Type field, which is set based on the Due in Days reporting rule parameter. Otherwise, Vault selects checkboxes based on the following logic:
  • 5-day: When the Device Report Type field on the Case contains Public Health Risk.
  • 7-day: When the Case is tagged as a SUSAR and when the Seriousness field on the Case contains Fatal or Life-Threatening.
  • 15-day: Vault selects this checkbox using the following logic:
    • For an initial study Case, the Case is tagged as a SUSAR and does not qualify for the 7-day option (the Seriousness field on the Case is not Fatal or Life-Threatening).
    • For an initial postmarket spontaneous Case, the Seriousness field on the Case is populated (serious) and the Case Expectedness field is set to No (unexpected).
    • For a follow-up postmarket spontaneous Case, the Seriousness field on the Case is populated (serious) and the Case Expectedness field is set to No (unexpected).
  • 30-day: For device malfunction-only reports.
  • Periodic: When any of the following conditions are met:
    • The Seriousness field on the Case is not populated (non-serious).
    • The Seriousness field on the Case is populated (serious) and the Expectedness field on the Casefield is set to Yes (expected).
    • The Case is a follow-up study Case tagged as a SUSAR.
  • Initial and Follow-up #: Vault selects these checkboxes using the following logic:
    • If a Transmission record exists for the Case and a value is populated in the Transmission Reason field:
      • If the Transmission Reason is Initial, Vault selects Initial.
      • If the Transmission Reason is populated with any other value, Vault selects Follow-Up #.
    • If there is no Transmission record associated with the Case:
      • If the Case New Info Date is less than or equal to the Case Receipt Date, the Type of Report is set to Initial.
      • If the Case New Info Date is greater than the Case Receipt Date, the Type of Report is set to Follow-Up.

When no report type applies based on the above criteria, Vault selects the Periodic checkbox.

Vault populates the Follow-up # value from the Follow-up Number field on the Submission record.
8. Adverse Event Term(s) The Event (MedDRA) or the Event (Reported) - English on the primary Case Adverse Event.
9. Manufacturer Report Number The UID on the Case.

H. Device Manufacturers Only

H. Device Manufacturers Only

FDA MedWatch 3500A Field Populated Value
1. Type of Reportable Event

Vault selects the Death checkbox if the Seriousness of any Case Adverse Event contains Results in death.

Vault selects the Serious Injury checkbox based on the value in the Device Report Type field on the Case.

Vault selects the Malfunction checkbox based on the Malfunction field on the primary Device-type Case Product. If that field is blank, Vault selects a checkbox based on the Device Report Type on the Case.
2. If Follow-up, What Type? Vault selects the appropriate checkboxes based on the Device Follow-Up Type on the Case.
3. Device Evaluated by Manufacturer Vault selects the appropriate checkbox based on the Device Evaluated value on the Case Product. If Yes is selected, the Evaluation Summary Attached checkbox is also selected.
4. Device Manufacture Date The Manufacture Date on the Case Product.
5. Labeled for Single Use? For Device-type Case Products, the Single Use value.
6. Event Problem and Evaluation Codes Codes in this section are populated as follows:

  • Patient Code: Depending on your Admin's configuration, this value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the Device-type Case Product if the Device Type Code was either Health Effects - Clinical signs and Symptoms or Conditions or Health Effects - Health Impact. Vault exports up to three Patient Codes.

    If no Patient Codes are found, the field is populated with Unknown. If there are more than three Patient Codes, all Patient Codes appear on the overflow pages instead of in this section.

  • Device Code: Depending on your Admin's configuration, this value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the Device-type Case Product if the Device Type Code was either Medical Device Problem or Medical Device Component. Vault exports up to three Medical Device Problem codes.

    If no Device Codes are found, the field is populated with Unknown. If there are more than three Device Codes, all Device Codes appear on the overflow pages instead of in this section.

  • Method: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the Device-type Case Product. Vault exports up to four Type of Investigation codes.

    If no Type of Investigation codes are found, the field is populated with Unknown. If there are more than four Type of Investigation codes, all appear on the overflow pages instead of in this section.

  • Result: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the Device-type Case Product. Vault exports up to four Investigation Findings codes.

    If no Investigation Findings codes are found, the field is populated with Unknown. If there are more than four Investigation Findings codes, all appear on the overflow pages instead of in this section.

  • Conclusions: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the Device-type Case Product. Vault exports up to four Investigation Conclusion codes.

    If no Investigation Conclusion codes are found, the field is populated with Unknown. If there are more than four Investigation Conclusion codes, all appear on the overflow pages instead of in this section.

To use IMDRF codes, your Admin must enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.
7. Remedial Action Initiated, Check Type Vault selects the appropriate boxes using the following priority order:
  • The Remedial Action field on the primary Device-type Case Product. When populated with Other, Vault exports the text in the Remedial Action Other field of the Case Product.
  • The Remedial Action field on the Case. When populated with Other, Vault exports the text in the Remedial Action-Other field of the Case.
8. Usage of Device Vault selects the appropriate box based on the Device Usage Type on the Device-type Case Product.
9. If action reported to FDA under 21 USC 360i(f), list correction/removal reporting number The Correction/Removal Reporting Number on the Device-type Case Product.
10. Additional Manufacturer Narrative The Additional Manufacturer Narrative on the Device-type Case Product. Text that exceeds the field character limit appears in the overflow pages under the heading H.10 Additional Manufacturer Narrative.
11. Corrected Data This field is not automatically populated.

Overflow Pages

When generating the FDA MedWatch 3500A form, Vault exports any text that exceeds field character limits to overflow pages. In the applicable field, Vault truncates the text to 15 characters and appends (Continued) to indicate the information is on the overflow pages. Any text on the overflow pages is identified with the relevant section and field names.